Manager, Regulatory LCM CMC

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management. Regulatory Execution Prepare, review, and submit post-approval CMC regulatory filings, including: Variations (Type IA/IB/II) Supplements (PAS, CBE-30, CBE-0) Annual reports and renewals Ensure submissions meet regional requirements (FDA, EMA, and other global health authorities). Track submission timelines and ensure on-time delivery. Change Management Evaluate CMC changes (manufacturing, analytical, raw materials, etc.) for regulatory impact. Support regulatory classification and filing strategy for change controls. Work closely with cross-functional teams to ensure appropriate documentation. Lifecycle Management Maintain and update Module 3 (CMC) sections of regulatory dossiers. Support product lifecycle activities including label updates (CMC-related), site transfers, and process improvements. Ensure compliance of existing licenses with updated regulatory requirements. Health Authority Interaction Support preparation of responses to queries, deficiency letters, and information requests. Assist in compiling documentation for regulatory inspections and audits. Cross-Functional Collaboration Collaborate with Quality, Manufacturing, Supply Chain, and Technical Operations teams. Participate in change control meetings and provide regulatory input. Communicate regulatory requirements clearly to stakeholders. Competencies Understanding of regional frameworks: US FDA (BLA lifecycle, supplements categories) EU EMA (Variation Regulation) Japan PMDA requirements Knowledge of biologics manufacturing processes : Cell culture, upstream/downstream processing Aseptic filling, sterility assurance Understanding of: Analytical methods & specifications Process validation and control strategies Familiarity with ICH guidelines (Q5E, Q6B, Q8–Q12) Understanding of: Supply chain implications of regulatory decisions Qualifications PhD 1 - 3 years, MS 4 - 6 years, BS 6 - 8 years in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent. Subject matter expertise in regulatory affairs and related activities. Previous experience in life cycle management activities with direct experience in variation filing for US, EU Ability to work in a matrix, teams, and diverse cultures is essential Fluency in English is essential, other languages are beneficial